Active Ingredient
Lidocaine HCl 0.5%
Sunburn Relief Gel
FDA Label NDC 30400-605
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jell Pharmaceuticals Pvt. Ltd for the product Sunburn Relief Gel (NDC 30400-605). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, do not use, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
External analgesic
Uses
for the temporary relief of pain and itching associated with
- minor burns
- sunburn
- minor cuts
- scrapes
- insect bites
- minor skin irritations
Warnings
For external use only
When Using This Product
avoid contact with the eyes
Do Not Use
in large quantities, particularly over raw surfaces or blistered areas
Stop Use And Ask A Doctor If
condition worsens, or if symptoms persist for more than 7 days or clean up and occur again within a few days
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
Inactive Ingredients
water, propylene glycol, glycerin, Aloe Barbadensis Leaf Juice, sodium hydroxide, isopropyl alcohol, polysorbate 80, carbomer, phenoxyethanol, benzyl alcohol, menthol, disodium EDTA, blue 1, yellow 5
Principl Display Panel
sunburn relief gel
Pain Relieving Gel
with Aloe Vera and Lidocaine HCl
Label (Photo 2025 01 30 19 44 11)
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